Regulatory Affairs Specialist
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Limburg Belgium.
They are a manufacture of high tech medical equipment and a global leader and provider of their products. Due to growth of their company and increasing pressure on the regulatory aspect they are looking for extra support in their regulatory team.
ROLE DESCRIPTION
As the RA specialist you will be responsible for the documentations and registrations of the products within the company. You will work close with the team and help the products get certified for ISO 13485 and CE markings. You will focus on the RA aspect of all products but will work together with the QA team to come to an successful registration and documentations.
RESPONSIBILITIES
- Manage RA projects, documentations and registrations
- Implement, improve and secure regulatory compliancy
- Participating and securing Risk analysis
- Participating in meetings and providing advice from a Regulatory perspective
- Developing a plan and roadmap to follow
- Drafting and reviewing various product related documentation
- Advising and supporting stakeholders with regard to statistical substantiation
- Monitoring the progress and drafting to come to a complete technical file
REQUIREMENTS
- 3 to 5 years of experience in RA, Medical Device experience is a big plus
- Familiar with registrations and documentations of Devices and CE-marking
- Fluent in English and preferably Dutch
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
